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Completed

NCT Number: NCT02197624

Genetic Variants and Iron Absorption

The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian women. The investigators hypothesize that the genetic variant could enhance iron status and iron absorption in Asian women.

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Key information

Conditions

Iron Absorption

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

About this study

To determine the HFE genotype of female Asian study volunteers, we collected venous blood samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT, and TT and used to assess possible differences in iron status as a function of genotype. To measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a blood sample was collected from each woman and the amount of non-heme (57Fe) iron incorporated into red blood cells was measured with magnetic sector thermal ionization mass spectrometry. Possible associations between iron status and iron absorption as a function of genotypes were explored. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of individuals with different genetic background.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non-pregnant and between the ages of 18~35 y
  • East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore

Exclusion criteria

  • taking or planing to take any vitamin or mineral supplements during the study period
  • pre-existing medical problems that might impact inflammation or Fe status, including malabsorption, blood disorders, ulcers, joint diseases and asthma
  • taking any prescribed medications known to affect iron homeostasis

Treatment and study plan

Primary outcomes

  1. Genotype at SNP rs9366637

    Time frame: 2 weeks after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.

  2. Hemoglobin

    Time frame: Up to 2 days after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.

  3. Serum Ferritin

    Time frame: Up to 6 months after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.

  4. Serum transferrin receptor

    Time frame: Up to 6 months after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.

  5. Non-heme Iron absorption in women with 2 HFE genotypes

    Time frame: one month for screening with genotype then 2 weeks for iron absorption study

    Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.

Secondary outcomes

  1. Folate

    Time frame: Up to 6 months after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of folate.

  2. Vitamin B-12

    Time frame: Up to 6 months after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of vitamin B-12.

  3. C-reactive protein

    Time frame: Up to 6 months after the participant's visit to the laboratory

    At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of C-reactive protein.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Official study title

Metabolic Adaptation to Plant-based Diets in Asian Populations

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 23, 2014
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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